Development Strategies For Adenovirus-Based Gene Therapies

By Eva Fong and Ayan Dey, Viral Vector Process Development

Developing and manufacturing viral vectors for cell and gene therapies is a complex process that requires a focus on both quantity and quality. While high titers are important, other factors, such as vector heterogeneity, capsid ratios, and aggregation, can significantly impact a process's success.

Scaling up viral vector production can be particularly challenging, as processes may not translate linearly from smaller to larger scales. Ensuring consistent titers and activity requires careful optimization and technical expertise. A multi-departmental project team, composed of experts in foundational science, analytics, and biomanufacturing, is essential for overcoming these challenges. Such a team can provide the necessary guidance and support throughout the development and manufacturing process.

A customer-centric approach is likewise crucial for successful viral vector production. By working closely with clients and understanding their specific needs, organizations can provide tailored solutions and address challenges effectively. Moreover, by focusing on both quantity and quality, and by leveraging a multidisciplinary approach and strong partnerships, organizations can successfully develop and manufacture high-quality viral vectors for cell and gene therapies. This will ultimately contribute to the advancement of these innovative treatments and improve patient outcomes.